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Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN) (LIFETRAIN)

7 maj 2026 uppdaterad av: Isabel Maurus, Ludwig-Maximilians - University of Munich

Personalised Pharmaco-Lifestyle Interventions for Severe Mental Illnesses Enhanced by Digital Health and Immersive Technologies

This randomized, rater-blind, multicenter clinical trial will evaluate whether a personalized pharmaco-lifestyle intervention improves mental functioning in adults with severe mental illness, including schizophrenia, bipolar disorder, or major depressive disorder. Participants will be randomized to either a modular individualized intervention program or a structured psychoeducation control condition. The individualized intervention may include physical exercise, an anti-inflammatory diet, sleep intervention, social prescribing, semaglutide for eligible participants with overweight or obesity, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. The primary outcome is change in the SF-36 Mental Component Summary score from baseline to Month 3.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

140

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Nederländerna
      • Groningen, Nederländerna, 9713 GZ
        • University Medical Center Groningen
      • Utrecht, Nederländerna, 3584 CX
        • University Medical Center Utrecht
  • Tyskland
      • Mannheim, Tyskland, 68159
        • Central Institute of Mental Health
      • München, Tyskland, 80336
        • Department of Psychiatry and Psychotherapy, LMU Klinikum
  • Österrike
      • Vienna, Österrike, 1090
        • Medical University of Vienna

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age 18 to 65 years
  • Able and willing to provide written informed consent
  • Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder according to DSM-5-TR, confirmed by M.I.N.I.
  • Female participants of childbearing potential must agree to use an effective method of contraception
  • Stable psychopathology defined as BPRS less than or equal to 41, MADRS less than or equal to 34, and YMRS less than or equal to 25, with stable psychopharmacological treatment for at least 2 weeks
  • Reduced functioning at screening defined as SF-36 score less than or equal to 40
  • If using benzodiazepines, dose less than or equal to 2 mg lorazepam equivalent per day
  • Stable somatic condition for at least 4 weeks
  • For semaglutide treatment: overweight with BMI at least 27 and less than 30 kg/m² plus at least one weight-related risk condition, or obesity with BMI at least 30 kg/m²
  • For optional adaptive neurostimulation: MADRS score at least 19
  • Expected ability to comply with study procedures in the investigator's judgment

Exclusion Criteria:

  • Unable to provide informed consent
  • Current or past neurological disorder or structural brain pathology that may affect study procedures
  • Known intolerance or hypersensitivity to semaglutide
  • Pregnancy or lactation
  • Serious suicidal risk
  • Substance dependence within the last 3 months
  • BMI less than 18.5 kg/m²
  • eGFR less than 30 mL/min/1.73 m²
  • Type 1 diabetes, diabetic ketoacidosis, diabetic retinopathy, or poorly controlled diabetes with recurrent hypoglycemic episodes
  • Pancreatitis, history of pancreatitis, or pancreatic cancer
  • Multiple endocrine neoplasia type 2 or personal/family history of medullary thyroid cancer
  • Pre-existing significant gastrointestinal conditions such as inflammatory bowel disease or gastroparesis
  • Need for acute surgery
  • Other medical condition that may affect study procedures or participant safety
  • For optional adaptive neurostimulation: nonremovable metal in or around the head, known increased intracranial pressure due to infarcts or trauma, professional metal work or prior ocular metal injury, history of rTMS or ECT, or current (es)ketamine treatment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Personalized pharmaco-lifestyle intervention
Participants receive one or more individualized intervention modules selected according to predefined eligibility criteria, digital guidance, and shared decision-making. Modules may include exercise, anti-inflammatory diet, sleep intervention, social prescribing, semaglutide, and optional closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms. Weekly guided support is provided through Month 3, followed by self-directed continuation with digital support through Month 6.
Läkemedel: Semaglutide (SEMA)
Once-weekly subcutaneous semaglutide for eligible participants with overweight or obesity and metabolic risk, titrated according to protocol up to 2.4 mg/week as tolerated, followed by tapering after Month 6.
Beteende: Exercise module
Personalized moderate-intensity exercise intervention with supervised sessions during the structured phase and supported maintenance, targeting at least 150 minutes of moderate physical activity per week.
Beteende: Anti-inflammatory diet module
Structured anti-inflammatory dietary intervention based on the Brain Anti-Inflammatory Nutrition (BrAIN) diet, supported by coaching, recipes, and digital materials.
Beteende: Sleep intervention module
Adapted cognitive behavioral therapy for insomnia (SLEEPexpert) including a structured introduction and supported self-management.
Beteende: Social prescribing module
Structured intervention to increase social participation, community engagement, and behavioral activation.
Enhet: Closed-loop transcranial alternating current stimulation (CL-tACS)
Optional adjunctive bifrontal closed-loop transcranial alternating current stimulation for participants with prominent depressive symptoms.
Aktiv komparator: Structured lifestyle psychoeducation control
Participants receive structured psychoeducation and counseling on exercise, diet, sleep, and social contact approximately every four weeks through Month 3, followed by self-guided continuation through Month 6. Participants with prominent depressive symptoms may receive sham closed-loop transcranial alternating current stimulation.
Beteende: Structured lifestyle psychoeducation
Control intervention consisting of psychoeducation and counseling on lifestyle domains with self-guided continuation.
Enhet: Sham CL-tACS
Sham closed-loop transcranial alternating current stimulation in the control arm for eligible participants with prominent depressive symptoms.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (MCS) score
Tidsram: Baseline to Month 3
Change from baseline in the SF-36 Mental Component Summary score.
Baseline to Month 3

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary score (MCS) at Month 6
Tidsram: Baseline to Month 6
Baseline to Month 6
Change in Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) score
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Short Form 36 Health Survey (SF-36) total score
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in MATRICS Consensus Cognitive Battery
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Insomnia Severity Index (ISI)
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in UCLA Loneliness Scale score
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in International Physical Activity Questionnaire
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in EQ-5D-3L score
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Incidence of adverse events and serious adverse events
Tidsram: Baseline through day 240-243
Baseline through day 240-243
Change in Brief Psychiatric Rating Scale (BPRS) psychotic symptoms
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Montgomery-Åsberg Depression Rating Scale (MADRS)
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Young Mania Rating Scale (YMRS)
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in Pittsburgh Sleep Quality Index (PSQI) scores
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in step aerobic test performance
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in grip strength
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body weight
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in body mass index (BMI)
Tidsram: Baseline to Month 3 and Month 6
Weight and height will be combined to report BMI in kg/m^2
Baseline to Month 3 and Month 6
Change in waist-to-hip ratio
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Chage in blood pressure
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in lean mass
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6
Change in fat mass
Tidsram: Baseline to Month 3 and Month 6
Baseline to Month 3 and Month 6

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ludwig-Maximilians - University of Munich

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2028

Primärt slutförande (Beräknad)

1 juli 2030

Avslutad studie (Beräknad)

1 december 2030

Studieregistreringsdatum

Först inskickad

9 april 2026

Först inskickad som uppfyllde QC-kriterierna

7 maj 2026

Första postat (Faktisk)

14 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LIFETRAIN
  • U1111-1340-3272 (Annan identifierare: Universal Trial Number (UTN))

Plan för individuella deltagardata (IPD)

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